Recombined bifunctional plasmin freeze-drying preparation for injection and preparation method thereof

Abstract

The invention discloses a recombined bifunctional plasmin freeze-drying preparation for injection and a preparation method thereof. The recombined bifunctional plasmin freeze-drying preparation is prepared from a recombined bifunctional plasmin stock solution, mannite, a Tris buffer solution, tween 80, zinc chloride and sterile injection water. The preparation method comprises the following steps of: respectively preparing the mannite, the Tris buffer solution, the tween 80 and the zinc chloride into diluents by using the sterile injection water, and then regulating the recombined bifunctional plasmin stock solution until the concentration is 100 mg/ml; mixing in proportion, then filtering by using a microporous filtering film, and charging into bottles in a splitting manner; and freeze-drying to form the finished preparation in the shape of a powder block. The finished preparation is preserved under the condition of 2-8 DEG C, and the preservation period of the active components of the finished preparation can reach 30 months. The invention has stable property and double functions of thrombolysis and platelet aggregation inhibition, can be preserved for a long time by being accelerated at 55 DEG C for 3 months and accelerated at 37 DEG C for 6 months and at room temperature, keeps the plasmin content and the solubility basically unchanged without obvious degradation and keeps the activity more than 80 percent.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a freeze-dried preparation of recombinant bifunctional plasmin for injection and a preparation method thereof. Background technique [0002] Fibrolase is a zinc metalloprotease from the American southern copperhead (Agkistrodon contortrix contortrix), which has fibrinolytic activity and no hemorrhagic activity. It is a polypeptide chain composed of 203 amino acid residues, with a molecular weight of 23kD and a cyclized glutamate residue at the N-terminal. 1 mol of zinc atom is bound to 1 mol of Fibrolase protein, and the loss of zinc will lead to its rapid inactivation (Ahmed NK, et al. Haemostasis. 1990, 20 (3): 147-154). [0003] Fibrolase can specifically degrade fibrin fibril protein (original), making it into 45kDa and 22.5kDa fragments. Studies have shown that the thrombolytic mechanism of Fibrolase is completely different from the clinically used solvent t-PA and strept...

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Problems solved by technology

However, there is no report on the use of this high-purity target protein with dual functions of thrombolysis

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